The study is a randomized, controlled trial comparing music therapy associated to NRT versus NRT alone to evaluate the value of music therapy in improving the management of craving among 120 student smokers (18 to 25 years old). This pilot multi-method study will combine the methodology of clinical trials with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a young audience.
The participants will be recruited at the Clinical Investigation Center (CIC) of the University Hospital of Poitiers. At baseline visit, they will be randomly 1:1 assigned to receive either music therapy and NRT or NRT alone for 3 months. During the 3 months after TQD (Target Quit Date), 3 visits will be performed by practitioners at the CIC. Practitioners will register smoking status of the participant, exhaled carbon monoxide concentration, body weight and all adverse events. Participants will answer questionnaires (FTCQ-12, HAD, MNWS, UPPS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Music therapy carried out with MUSIC CARE©
NRT: Nicotine Patch, Nicotine Gum
CHU Poitiers
Poitiers, France
RECRUITINGAssess if Music therapy associated to NRT decrease tobacco craving compared to NRT alone
Score of French Version of the Tabacco Craving Questionnaire-12 (FTCQ-12). It consist of 12 questions, each rated on a likert-type scale with 7 response options. Lower scores mean a better outcome.
Time frame: Month 1
Test the feasability of such a program in smoking cessation
Music therapy sessions compliance. Number and reasons for not attending music thearpy sessions.
Time frame: Month 3
Evaluate the evolution of tobacco craving
Score of French Version of the Tabacco Craving Questionnaire-12 (FTCQ-12). It consist of 12 questions, each rated on a likert-type scale with 7 response options. Lower scores mean a better outcome.
Time frame: Month [2; 3]
Evaluate the evolution of Anxiety
HAD (Hospital Anxiety and Depression Scale) score. Maximum score for each score (total A, total D) = 21. Score over 10 definites state of anxiety. Lower scores mean a better outcome.
Time frame: Month [1;2; 3]
Evaluate the evolution of nicotine withdrawal symptoms
MNWS (Minnesota Nicotine Withdrawal Scale) score. It consist of 8 questions, each rated on a likert-type scale with 0-4 response options. Lower scores mean a better outcome.
Time frame: Month [1;2; 3]
Evaluate the evolution of impulsivity
UPPS (Impulsive Behavior Scale) score. It consist of 20 questions, each rated on a likert-type scale with 1-4 response options. Lower scores mean a better outcome.
Time frame: Month [1;2; 3]
Evaluate the efficacy of the intervention on smoking cessation
Self reported abstinence or smoking reduction \>or=50%
Time frame: Month [1;2; 3]
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